MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-11 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[179492109]
Device evaluated by mfr: device analysis revealed that the device had a detachment in the lapjoint section. The device had the imaging window detached and the imaging window did not return with the device. Additionally, kink was observed in the imaging core and sheath assembly, hence, the reported complaint of "failure to advance" was confirmed due the kink found. The reported complaint of "lost image" was not confirmed due the condition of the device. Even so, it is important to mention that a impedance inspection was performed and the device showed a good curve line, furthermore, the transducer appears to be in good condition.
Patient Sequence No: 1, Text Type: N, H10
[179492110]
Reportable based on device analysis completed on 17jan2020. It was reported that the device was unable to cross the lesion. The target lesion was located in the severely tortuous and moderately calcified right coronary artery. The opticross catheter was advanced but was unable to cross the lesion. Pullback was performed, but the image immediately disappeared. The procedure was competed with a different device. No patient complications were reported. However, device analysis revealed a detached imaging window from the lap joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01339 |
| MDR Report Key | 9695662 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICROSS |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2019-12-20 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0024307580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |